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OpenTrials
Completed

NCT Number: NCT00256399

Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

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Key information

Conditions

BPH Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

About this study

The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males 45-75 years of age
  • Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
  • Men with steady partner and who agree to attempt sex once a week.

Exclusion criteria

  • Prostate cancer
  • Prostatitis
  • Penile disease
  • Cardiac co-morbidity
  • Pre-existing co-morbid conditions
  • History of sensitivity to the drug or similar drugs
  • Enrollment in another clinical trial
  • Impaired hepatic function
  • Impaired renal function
  • Mental conditions rendering subject unable to understand the study
  • Subjects not likely to comply with protocol

Treatment and study plan

Alfuzosin 10 mg

Drug

Primary outcomes

  1. Evaluate the medication on erection maintenance

Secondary outcomes

  1. Assess effect of Uroxatral on BPH and sexual function using questionnaires

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Sanofi

Registry information

Official study title

A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 21, 2005
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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